Have you been unable to find relief with standard antidepressant medication?

If so, you may be eligible to participate in this clinical trial. This study is testing whether the combination of the drugs brexpiprazole and intranasal ketamine can safely and effectively treat people who are already taking an antidepressant medication, but have not had a satisfactory response.

Who can take part?

To pre-qualify for this study, you must:

be 18 to 65 years of age

currently be struggling with depression

currently be taking an antidepressant

have been unable to find relief with standard antidepressant medication

What happens if you decide to participate?

The study requires 12 visits to our research clinic over a period of 5 to 8 weeks, depending on the length of the screening portion. Please contact us if you or someone you know is interested in learning more about this study. Participants will receive compensation for their time.

You will receive:

We will pay you $ 270 - $ 825 if you complete the study. If you do not complete the study, we will pay you $ 20-$ 75 for each visit you complete.

We will pay for your parking in the hospital garage during study visits.

How to apply

Please register on this website and answer the questions below. If you are eligible, one of the participating clinics will contact you to schedule an appointment, and will also be happy to answer any questions you may have.

Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used with other drugs for anesthesia and as a pain reliever during procedures. However, ketamine is not approved by the FDA to treat depression. Brexpiprazole (Rexulti) is approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

What is a clinical study?

A clinical study is a scientific study on how a new or existing medicine, product, procedure or treatment works in people.

Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.

All clinical studies are carefully monitored and regulated to ensure participant well-being.

Participating in a clinical study is completely voluntary and will not affect the normal standard of care you receive.

What is the study about?

We are doing this research study to find out if brexpiprazole in combination with intranasal ketamine is effective in treating Major Depressive Disorder (MDD) in adult patients with MDD who have not responded to treatment with antidepressants alone. We also want to find out if brexpiprazole in combination with intranasal ketamine is safe for people who are already taking a drug treatment for MDD.

Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used with other drugs for anesthesia and as a pain reliever during procedures. However, ketamine is not approved by the FDA to treat depression. Brexpiprazole (Rexulti) is approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

This research study will compare (brexpiprazole (pill) + intranasal ketamine) to (placebo pill + intranasal ketamine). A placebo is a treatment that appears identical to the drug but that contains no drug with known antidepressant activity. During this study, in addition to intranasal ketamine, you may get placebo (pretend treatment) instead of brexpiprazole. Placebos are used in research studies to see if the results are due to the study drug or other reasons.

How long will I take part in this research study?

This study has an initial screening period, which will range from a minimum of 7 days to a maximum 28 days. The purpose is to ensure that only appropriate patients are entered into the study. If you are found eligible, you will be enrolled into the study and it will take you approximately 4 weeks to complete this research study. During this time, we will ask you to make 12 study visits to research center.

What will happen during this study?

Before you can participate in this study, you will be screened for eligibility. If you are eligible, and you agree to participate, you will be randomly assigned (like flipping a coin) to receive injections of either the investigational drug or the placebo. You have a 50% chance of receiving the investigational drug and a 50% chance of receiving the placebo.

During your clinic visits for the study, doctors and the study staff will also conduct various tests and assessments to evaluate your health and progress. Some of these tests and assessments include, but are not limited to:

Vital signs measurements

Physical exams

Blood and urine sample collections

ECG (electrocardiogram) This test checks the electrical activity of your heart. We will place several small, sticky pads on your chest, arms, and legs. Each pad has a wire attached. The wires connect to a machine that makes a recording of your heart rhythm. This painless test takes about 15 minutes.

Reviews of medication you are taking

Reviews of any side effects

If you join the study, you can stop taking part at any time. If you choose to leave the study, doctors and the study staff will ask you to undergo some tests and assessments so they can evaluate your safety.

What are the risks and benefits related to this study?

You may or may not benefit from taking part to the study. It is possible that your depression symptoms will improve while you are taking part in the study. The study may also benefit other people with MDD by furthering our understanding of the antidepressant effectiveness and safety of ketamine.

The study staff will provide you with a complete list of known side effects related to this product.

Because research studies can affect the health and safety of participants, you will be closely monitored during this study. Researchers designed a protocol for this study, which explains all of the study procedures in complete detail. An independent review board responsible for participant safety reviewed and approved this protocol and requires that it be followed exactly.

What if I have questions?

The study staff is always available to answer any questions or concerns you may have about the study or the investigational drug.

2. Are you currently experiencing a major depressive episode of at least 8 weeks?

3. Are you currently taking anti-depressant medication?

4. Have you been treated with standard antidepressant medication, without finding relief?

5. Do you have a history of bipolar disorder, schizophrenia or schizoaffective disorder?

6. Are you pregnant or breastfeeding?

How did you hear about us?

Privacy statement

I hereby consent with the processing of my personal data as stipulated in the: Privacy statement

PRIVACY STATEMENT April 2018

Link2Trials respects the privacy of the users of its website. We process personal data only for the purpose for which it was provided and in accordance with the Privacy Act and the Telecommunications Act.

About us

Link2Trials is the controller for the processing of your personal data within the meaning of the Privacy Act.

What data do we collect?When you register an account, you will be asked to fill out data.

We will request your name, address, postcode, and town/city to contact you; for example, to make appointments or send you information.

In addition, we will need your phone number to contact you and send you a reminder message.

To create your account, we will ask for your email address. We also need this information to contact you by email; for example, to send you confirmation and reminder emails. In addition, we send emails to inform you of any new trials.

We need your address, postcode, and town/city in order to display local trials or studies within a certain radius.

Your time zone and locale are processed to display the correct time and language for you.

Your IP address is processed to protect your account.

These personal data are necessary for the intended and actual performance of an agreement. Without this information, we will not be able to enter into an agreement or use you as a trial subject. In addition, we will ask you for your prior consent to process of this data.

Research purposes: “special personal data” In addition, certain information is requested for research purposes in order to see whether you are a match with the trial in question and to carry out the study. This information includes personal data with respect to your gender, age, ethnicity, level of education, medication use, fertility, height and weight, alcohol consumption, smoking habits, and other medical data and/or data concerning health.

A large part of this information is ‘special personal data’ in the sense of the GDPR. Because this information is sensitive, we treat it with care. This data will only be processed with your explicit consent.

Who do we share your personal data with? Your personal data may be provided to third parties who will take on part of the processing for the benefit of Link2Trials. For example, we use an external party to provide dedicated hosting for the personal data. This party is certified to store medical data and is a processor within the meaning of the GDPR.

After you have enrolled in a specific study or project, your personal data will be shared with research institutions, who may or may not contact you to participate in trials or studies.

We verify in advance whether these organizations are recognized organizations and thus comply with national laws and regulations. These parties shall have access to the personal data of their studies. In principle, your personal data will only be passed on to research institutions in the country where you live.

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Retention period We will not keep your data longer than necessary for the purpose for which it was received.

In principle, your personal data will be saved until you cancel your account with us. When you cancel your account, the personal data will be deleted within 72 hours at the latest.

We ask inactive accounts to reactivate their account by email. Personal data in accounts that have been inactive for more than 10 years will be deleted after this period.

The above periods apply unless there are further legal obligations for us to store the data or keep them available for longer.

Rights You have the right to inspect your personal data and the right to rectify your personal data. If you want to know which of your personal data we process, you can submit a written Data Subject Access Request (DSAR). Should your data be incorrect, incomplete or irrelevant, you can ask us in writing to alter or supplement your data.

If you have given us your consent to process certain of your data, you are always entitled to withdraw this consent. The withdrawal of this consent does not prejudice the lawfulness of our processing on the basis of your consent, which took place prior to this withdrawal.

You also have the right to have your personal data erased, the right to restrict their processing and the right to object to their processing. In addition, you have the right to transfer your data or to make them transferable (the so-called “right to data portability”). You can also submit a written request to this end.

“Written” here includes email. You can email your request to us via helpdesk@link2trials.com. We will process your request within four weeks.

You also have the right to complain about the way in which we handle your data. You can submit any such complaints to the Federal Trade Commission.

Changes We reserve the right to make changes to this privacy statement. The amendments shall enter into force on the date announced for their entry into force.

Thank you! Your application has been received! . You will receive an email which you must confirm. You will get a response within weeks